97(b) procedures are established and implemented for protecting the integrity of data. Such procedures should include,
but are not limited to, measures to ensure the integrity and con dentiality of data entry or collection and the storage, transmission and processing of data. In particular, electronic data should be protected from unauthorized access and an audit trail of any amendments
should be maintained;
(c) computers and automated equipment are maintained so as to function properly and are provided with the environmental and operating conditions necessary to ensure the integrity of test and calibration data;
(d) procedures are established and implemented for making, documenting and controlling changes to information stored
in computerized systems and(e) electronic data should be backed up at appropriate regular intervals according to a documented procedure. Backed-up data should be retrievable and stored in such a manner as to prevent data loss.
Note: For further guidance on validation of data-processing equipment, refer to documents
published by the International Society for Pharmaceutical Engineering (
13, 14), US
Food and Drug Administration (
15), European Commission (
16) and the Of cial Medicines Control Laboratories Network of the Council of Europe (
17).
6.
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